BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 10864730 · Received November 18, 2020

    Report

    Report Number
    2024168-2020-09706
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 29, 2020
    Report Date
    January 12, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    UDI-DI
    08717648013089
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ACTUAL DATE OF EVENT. AS IT COULD NOT BE CONFIRMED IF THE LOT NUMBER FOR THIS COMPLAINT IS 0083041 OR 0090941, REVIEW OF THE MANUFACTURING RECORDS OF BOTH LOT NUMBERS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOTS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THESE LOTS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) INTERVENTIONAL PROCEDURE. THE LOT NUMBER WAS EITHER IS 0083041 OR 0090941. REPORTEDLY, THE DISTAL GUIDE SEPARATED FROM THE REST OF THE PROGLIDE DEVICE DURING ADVANCEMENT INTO THE ARTERY AND REMAINED IN THE PATIENT ANATOMY. CUT DOWN SURGERY WAS PERFORMED. A SNARE WAS USED TO REMOVE THE SEPARATED DISTAL GUIDE PORTION OF THE PROGLIDE FROM THE PATIENT ANATOMY. SURGICAL SUTURING WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. AS THE ORIGINAL PROCEDURE (TAVR) WAS ABORTED AND THE PATIENT REQUIRED CUT DOWN SURGERY, THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN PUNCTURE CLOSURE OF AN UNSPECIFIED VESSEL WAS ATTEMPTED USING A PROGLIDE DEVICE. REPORTEDLY, THE DISTAL GUIDE SEPARATED FROM THE REST OF THE PROGLIDE DEVICE AND REMAINED IN THE PATIENT ANATOMY. CUT DOWN SURGERY WAS PERFORMED TO REMOVE THE SEPARATED DISTAL GUIDE PORTION OF THE PROGLIDE FROM THE PATIENT ANATOMY AND TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327843 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 12673-03 08717648013089

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention